Evaluation of sealant retention and caries prevention of 2 % chitosan-based pit and fissure sealants in permanent 1st molars - A randomised trial.

Background: Dental caries is a significant public health concern, particularly in children, where occlusal surfaces are at high risk due to complex pit and fissure morphology. Pit and fissure sealants are a well-established preventive measure, with resin-based sealants offering superior retention compared to glass ionomer cement (GIC) sealants. Chitosan, a naturally derived biopolymer, may enhance resin-based sealants by improving their mechanical strength, antibacterial action, and adhesion, leading to better retention and reduced need for reapplication. This study evaluated the 6-month retention and caries-preventive effectiveness of a 2 % chitosan-modified resin-based sealant versus a conventional sealant. Methodology: A double-blind, split-mouth randomised clinical trial (CTRI/2023/06/054321) was conducted in a pediatric dental setting. A total of 38 children aged 6-10 years, each with four fully erupted, caries-free permanent first molars, were enrolled, resulting in a total of 152 Molars out of which 32 children (128 teeth) completed the trial. Each participant received both a conventional resin-based sealant (Clinpro™) and a 2 % chitosan-modified Clinpro™ sealant on contralateral molars. Randomisation was performed using a SNOSE (Sequentially Numbered Opaque Sealed Envelope) to determine the allocation of sealants on each side. Teeth were prepared by professional prophylaxis using pumice slurry, followed by etching with 37 % phosphoric acid, rinsing, and drying per manufacturer's instructions before sealant application. Both sealants were light-cured for 20 s and evaluated for proper placement. Clinical assessments were conducted at baseline, 3 months, and 6 months. Primary outcomes included sealant retention, evaluated using modified retention criteria (complete, partial, or total loss), and caries incidence, assessed using the International Caries Detection and Assessment System-II (ICDAS-II). Data were analyzed using STATA 18 software, and statistical significance was determined using Chi-square test to compare categorical variables, Shapiro-Wilk test was used to assess normality. Friedman test was conducted for within-group comparisons over time, followed by the Durbin-Conover post-hoc test for pairwise comparisons. Between-group comparisons of ICDAS-II scores were conducted using the Wilcoxon signed rank test. Statistical significance was set at Results: At 3 months, complete retention was observed in 95.31 % of molars treated with the chitosan-modified sealant, compared to 81.25 % in the conventional sealant group. By 6 months, retention rates declined slightly to 92.19 % in the study group and 76.56 % in the control group, with the differences remaining statistically significant (p < 0.05). Regarding caries prevention, at 3 months, 100 % of teeth in the study group remained caries-free (ICDAS-II score 0), compared to 89.06 % in the control group. By 6 months, 95.31 % of teeth in the study group remained caries-free, whereas the percentage dropped to 84.38 % in the control group. The chitosan-modified sealant demonstrated significantly superior caries prevention compared to the conventional resin-based sealant. Conclusions: The incorporation of 2 % chitosan into resin-based sealants significantly enhanced both retention and caries prevention over a six-month period. The bioadhesive and antimicrobial properties of chitosan likely contributed to these improved outcomes. Given its enhanced longevity and preventive benefits, chitosan-modified resin-based sealants may serve as a more effective alternative for pediatric dental care. Further studies with extended follow-ups and larger sample sizes are recommended to validate these findings.